We are studying a diabetic ( type II) population with decompensated heart failure. Our aim is to see wether Cardiac index and "wedge pressure", measured by heart catheterization, can improve with an infusion of Exenatide. Studied at a diabetic ( type II) population with decompansated heart failure. Patients with acute myocardial ischemia will be excluded. MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus MedDRA version: 9.1 Level: LLT Classification
Conditions
Interventions
Product Name: Exenatide
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Exenatide
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0,25
Sponsors
Karolinska institutet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1: Decompensated heart failure ( NYHA 3-4) despite optimal treatment with diuretics and ACE inhibitors/ AT II antagonists. 2: Type II diabetes. 3: Ejection fraction =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1: Type 1 diabetes. 2: Cancer. 3: Acute infection. 4: Myocardial infarction or unstable angina pectoris the last 2 months before randomisation. 5: Renal failure (creatinine clearence < 30 ml/min) 6: Active psychiatric diease. 7: Anemia ( Hb < 90 g/l) 8: Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Can a 6- hour infusion of Exenatide increase cardiac index, measured by heart catheterization, with 25% at a diabetic population ( type II) with decompensated heart failure?;Secondary Objective: Can a 6- hour infusion of Exenatide decrease "wedge pressure", measured by heart catheterization, with 25% at a diabetic population ( type II) with decompensated heart failure?;Primary end point(s): The proportion of subjects achieving a 25 % relative increase in Cardiac Index (l/min/m2) after 6 hours infusion of Exenatide, measured with thermo dilution technique. | — |
Countries
Sweden
Outcome results
None listed